Physicians in the University of Maryland Medical Center's Inflammatory Bowel Disease (IBD) Program are actively involved in clinical research. For more information about current clinical trials or past publications, please click on the links below.

Clinical Trials

The UMB IBD program is a member of the Clinical Research Alliance of the Crohn's and Colitis Foundation of America. Currently, the UM IBD program offers the following clinical research studies for patients to participate in:

Gene Discoveries in Subjects with Crohn's Disease of African Descent

The goal of this study is to perform genetic studies to better understand the differences between African Americans and Caucasians with inflammatory bowel disease 

  • Status: Recruiting
  • For further information, please contact the principal investigator, Dr. Raymond Cross, at 410-706-1 IBD (1423) or email IBDResearch

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The goal of this study is to evaluate the safety of different doses of ABT-494 and determine how well it works, as well as the pharmacokinetics (PK) (how drug is absorbed, distributed, and eliminated in the body over time) of ABT-494 in subjects with moderate to severe Ulcerative Colitis (UC).

Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC-IBD) 

This study goal is to create a longitudinally followed, well phenotyped cohort of patients with IBD who have linked clinical data, self-reported outcome data, and biosamples that can be used for clinical and translational research that will lead to precision medicine strategies and new therapeutic targets that will improve the quality of life of patients with IBD.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC-1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis, True North Study.

The goals of this study are to see whether RPC1063 is safe and effective for the possible treatment of UC. To do this, a comparison will be made between patients who receive study drug and patients who receive placebo.

Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn’s Disease.

The goal of this study is to compare the effectiveness of the Specific Carbohydrate Diet and a Mediterranean style diet to induce symptomatic and clinical remission in patients with active Crohn’s disease.

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease.

The goal of this study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Crohn's disease (CD). This study will be enrolling patients  who are biologic-naïve and biologic experienced patients.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

The goal of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula. This study is a Phase 2, double-blind, randomized, multicenter study.

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

The primary objective of this Registry is to evaluate the long-term safety of HUMIRA® in moderately to severely active UC adult patients (18 years of age or older) who are treated per routine clinical practice.

Coming Soon

A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF AN ELECTRO-MECHANICAL INJECTION DEVICE (E-DEVICE) FOR THE SUBCUTANEOUS SELF-INJECTION OF CERTOLIZUMAB PEGOL SOLUTION BY SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS, ACTIVE ANKYLOSING SPONDYLITIS, ACTIVE PSORIATIC ARTHRITIS, ORMODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

The primary goal of the study is to evaluate the ability of subjects in the week 2 and week 4 groups to safely and effectively self-inject CZP using the e-Device

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The primary goal of the study is to evaluate the safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active ulcerative colitis. This is a Phase 3, double-blind, randomized, multicenter study of higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active UC.

Enrollment Closed

Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (MAPUS)

The goal of this study is to assess the efficacy and safety of an investigational fixed-dose combination of three antibiotics; clarithromycin, rifabutin and clofazimine (RHB-104), compared to placebo when used to treat the bacteria which may be a cause of Crohn’s disease. MAP US Study

The Impact of Medical Treatment on Sexual Function in Patients with Crohn’s Disease

The goals of this study are to compare the impact of different treatments for Crohn’s disease on short- and long-term sexual function.

SECURE: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia) for Crohn's Disease

The goals of this study are to assess the long-term safety of certolizumab pegol (Cimzia) for the treatment of Crohn’s disease.


We are also actively involved in a number of other research projects, including but not limited to:

  • Disparities in Treatment in Patients with Inflammatory Bowel Disease
  • Racial Differences in Disease Activity and Quality of Life in Patients with Inflammatory Bowel Disease
  • Do Anti-TNF agents increase the risk of complications after abdominal surgery?
  • Are Anti-TNF Agents Radiation-Sparing in Patients with Crohn's Disease?
  • What are the Risk Factors for Progression to Complicated Crohn's disease and Disability?
  • Differences in Serologic Expression to Microbial Antigens between Young and Older Patients with Crohn's Disease
  • What are the risk factors for vitamin D deficiency and impact of replacement on disease activity and quality of life in Inflammatory Bowel Disease?
  • What is the prevalence of sexual dysfunction and distorted body image in patients with Inflammatory Bowel Disease?
  • What is the impact of medical treatment on sexual function and body image in Inflammatory Bowel Disease?
  • What are the risk factors for chronic narcotic use in patients with Inflammatory Bowel Disease?
  • What is the accuracy of magnetic resonance imaging compared to operative and endoscopic findings in patients with Crohn's disease?
  • Does fecal bacterial populations correlated with complicated Crohn's disease and recurrence after surgery?

Publications

  1. Cross RK, Wilson KT, Binion DG. Polypharmacy and Crohn's disease. Aliment Pharmacol Ther 2005;21:1211-6

  2. Cross RK, Wilson KT, Binion DG. Narcotic use in patients with Crohn's disease. Am J Gastroenterol 2005;100(10):2225-9.

  3. Cross RK, Arora M, Finkelstein J. Acceptance of telemanagement is high in patients with inflammatory bowel disease. J Clin Gastroenterol 2006;40(3):200-8.

  4. Cross RK, Jung C, Wasan S, Joshi G, Sawyer R, Roghmann MC. Racial Differences in Disease Phenotypes in Patients With Crohn's Disease. Inflamm Bowel Dis 2006;12(3):192-198.

  5. Castro, HK, Cross, RK, and Finkelstein, J. Using a Home Automated Telemanagement System (HAT): Experiences and Perceptions in Patients with Inflammatory Bowel Disease. AMIA Annu Symp Proc 2006;872.

  6. Cross, RK, and Finkelstein, J. Feasibility and Acceptance of a Home Telemanagement System in Patients with Inflammatory Bowel Disease: A 6-Month Pilot Study. Dig Dis Sci 2007;52(2):357-364.

  7. Donovan, M, Lunney, K, Carter-Pokras, O, and Cross, RK. Prescribing Patterns and Awareness of Adverse Effects of Infliximab: A Health Survey of Gastroenterologists. Dig Dis Sci. Aug 2007;52(8):1798-1805.

  8. Dunnigan, M, Yfantis, H, Rapoport, AP, Hosseinzadeh, K, Gocke, CD, and Cross, RK. Large cell lymphoma presenting as a flare of colitis in a patient with common variable immune deficiency. Dig Dis Sci. 2007;52(3):830-4.

  9. Cross, RK, Lapshin, O, and Finkelstein, J. Patient Subjective Assessment of Drug Side Effects in Inflammatory Bowel Disease. J Clin Gastroenterol. 2008;42(3):244-51

  10. Flasar MH, Johnson T, Roghmann MC, Cross RK. Disparities in the use of immunomodulators and biologics for the treatment of inflammatory bowel disease: A retrospective cohort study. Inflamm Bowel Dis. 2008;14(1):13-9

  11. Flasar, M, Quezada, S, Bijpuria, P, Wu, Roger, and Cross, RK. Racial Differences in Extent, Severity, and Extraintestinal Manifestations in Patients with Ulcerative Colitis: A Retrospective Cohort Study. Dig Dis Sci. 2008;53(10):2754-2760

  12. Greenberg, R, Greenwald, B, Ioffe, O, Roth, S, and Cross, RK. Squamous Dysplasia of the Rectum in a Patient with Ulcerative Colitis Treated with 6-Mercaptopurine. Dig Dis Sci. 2008;53(3):760-4.

  13. Cross, RK. Another Anti-TNF Therapy for Patients with Crohn’s Disease (Summary of Schreiber, S, Khaliq-Kareemi, M, Lawrance, IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s Disease. N Eng J Med. 2007;357:239-250). Inflamm Bowel Dis. 2008;14(3):425-427.

  14. Warren, JW, Howard, FM, Cross, RK, Good, J, Weissman, M, Wesselmann, U,  Langenberg, P, Greenberg, P, and Clauw, D. “Antecedent non-bladder syndromes in a case control study of interstitial cystitis/painful bladder syndrome”. Urology. 2009;73(1):52-7.

  15. Quezada, S, Turner, P, Alexiev, B, Daly, B, and Cross, RK. “Severe Refractory Orofacial Crohn’s Disease: Report of a Case”. Dig Dis Sci 2009;54(10):2290-5.

  16. Cross RK, Cheevers N, Finkelstein J. Home Telemanagement for Patients with Ulcerative Colitis (UC HAT). Dig Dis Sci 2009;54(11):2463-2472.

  17. St. Charles, M, Weiss Smith, SR, Beardsley, R, Fedder, DO, Carter-Pokras, O, and Cross, RK. Gastroenterologists Prescribing of Infliximab: A National Survey. Inflamm Bowel Dis. 2009;15(10)1467-75.

  18. Cross R, Finkelstein J. Challenges in the design of a Home Telemanagement Trial for patients with ulcerative colitis. Clin Trials 2009;6(6)649-57.

  19. Ghazi, L and Cross, RK. Fever of Unknown Origin in an Immune Suppressed Patient with Crohn’s Disease: An Unusual Cause. Practical Gastroenterology 2010;34(11):42-46.

  20. Samimi, R, Flasar, MH, Kavic, S, Tracy, K, and Cross, RK. Outcome of Medical Treatment of Stricturing and Penetrating Crohn’s Disease: A Retrospective Study. Inflamm Bowel Dis. 2010;16(7):1187-1194.

  21. Cross, RK, Cheevers, N, Rustgi, A, Langenberg, P, and Finkelstein, J. A Randomized, Controlled Trial of Home Telemanagement in Patients with Ulcerative Colitis (UC HAT). Inflamm Bowel Dis 2012;18(6):1018-1025.

  22. Cross, RK. Application of Telemedicine for Inflammatory Bowel Disease: Review of the Literature and Future Implications. J Gastrointest Digest Sys. October 2011;1(e102).

  23. Flasar, MH, Cross, RK, and Doman, DB. Current and Future Role of Ulcerative Colitis Serogenomics. Gastroenterology and Hepatology. November 2011;7(11):720-727.

  24. Patil, SA, Rustgi, A, Quezada, SM, Flasar, MH, Vandermeer, F, and Cross RK. Anti-TNF Therapy is Associated with Decreased Imaging and Radiation Exposure in Patients with Crohn’s Disease. Inflamm Bowel Dis. 2013;19(1):92-98.

  25. Quezada, SM and Cross, RK. Association of Age at Diagnosis and Ulcerative Colitis Phenotype. Dig Dis Sci. 2012;57(9):2402-2407.

  26. Faust, AH, Halpern, LF, Danoff-Burg, S, and Cross, RK. Psychosocial Factors Contributing to Inflammatory Bowel Disease Activity and Health-Related Quality of Life. Gastroenterology & Hepatology. March 2012;8(3):1-9.

  27. McLean, LP, Shea-Donahue, T, and Cross, RK. Vedolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease. Immunotherapy. 2012;4(9):883-898.

  28. Patil, S and Cross, RK. Where We’re Going, We Don’t Need Appointments: the Future of Telemedicine in IBD. (Summary of Krier, M, Kaltenbach, T, McQuaid, K, et al. Potential Us of telemedicine to provide outpatient care for inflammatory bowel disease. Am J Gastroenterol. 2011;106:2063-7). Inflamm Bowel Dis. 2012;18(11):2199-2200.

  29. Quezada, SM, Steinberger, EK, and Cross, RK. Association of Age at Diagnosis and Crohn’s Disease Phenotype.  Age Ageing. August 2012;0:1-4.

  30. Patil, SA, Rustgi, A, Langenberg, P, and Cross, RK. Comparative Effectiveness of Anti-TNF Agents for Crohn’s Disease in a Tertiary Referral IBD Practice. Dig Dis Sci. 2013;58(1):209-215.

  31. Ghazi, LJ, Patil, SA, Rustgi, A, Flasar, MH, Razeghi, S, and Cross, RK. Step Up versus Early Biologic Therapy for Crohn’s Disease in Clinical Practice. Inflamm Bowel Dis. 2013;19(7):1397-1403.

  32. Syed, A, Cross, RK, and Flasar, MH. Anti-Tumor Necrosis Factor Therapy is Associated with Infections after Abdominal Surgery in Crohn’s Disease Patients. Am J Gastroenterol. 2013;108(4):583-593.

  33. Quezada, SM and Cross, RK. To Yeast or Not to Yeast: A Probiotic Question. (Summary of Bourreille, A, Cadiot, G, Le Dreau, G, et al. Saccharomyces Boulardii for the Prevention of Relapse in Crohn’s Disease: Results of a Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial. Clin Gastroenterol Hepatol). Clin Gastroenterol Hepatol. 2013;11(8): 988-990.

  34. McLean, LP, Cross, RK, and Shea-Donohue, T. Combined Blockade of IL-17A and IL-17F Prevents the Development of Experimental Colitis. (Summary of Wedebye Schmidt, EG, Larsen, HL, Kristensen, N et al. TH17 Cell Induction and Effects of IL-17A and IL-17F Blockade in Experimental Colitis. Inflamm Bowel Dis). Immunotherapy. 2013;5(9):1-3.

  35. Razeghi, S, Halvorson, CR, Gaspari, AA, and Cross, RK. Successful Treatment of Localized Pyoderma Faciale in a Patient with Crohn’s Disease. Gastroenterology & Hepatology. 2013;9(8):541-544.

  36. Cheng, FF, McLean, LP, and Cross, RK. What is the Role of Vedolizumab in the Era of Anti-TNF Agents. (Summary of Sandborn, WJ, Feagan, BG, and Rutgeerts, P et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med). Ann Transl Med. 2014;2(1):1-4.

  37. McLean, LP, Chun, J, and Cross, RK. “Right Lower Quadrant Pain in a Patient with IBD of Undetermined Type”. Clin Gastroenterol and Hepatol. 2014;12(4):A29-30.

  38. McLean, LP and Cross, RK. “Adverse Events in IBD: To Stop or Continue Immune Suppressant and Biologic Treatment”. Expert Rev Gastroenterol Hepatol. 2014;8(3):223-240.

  39. Patil, SA and Cross, RK. “Can You Hear Me Now? Frequent Telephone Encounters for Management of Patients with Inflammatory Bowel Disease. (Summary of Ramos-Rivers, CM, Regueiro, M, Vargas, EJ et al. Association Between Telephone Activity and Features of Patients with Inflammatory Bowel Disease. Clin Gastroenterol Hepatol). Clin Gastroenterol Hepatol. 2014;12(6):995-996. 

  40. Ghazi, LJ, Lydecker, AD, Patil, SA, Rustgi, A, Cross, RK, and Flasar, MH. Racial Differences in Disease Activity and Quality of Life in Patients with Crohn’s Disease. Dig Dis Sci. 2014;50(10):2508-2513.

  41. Osterman, MT, Aberra, FN, Cross, R, Liakos, S, McCabe, R, Shafran, I, Wolf, D, Hardi, R, Nessel, L, Brensinger, C, Gilroy, E, and Lewis, JD. A Randomized Controlled Trial of Mesalamine Dose Escalation for Ulcerative Colitis in Remission. Clin Gastroenterol Hepatol. 2014;12(11):1887-93.

  42. Flasar, MH and Cross, RK. What is the need for comparative effectiveness studies in IBD? Expert Rev Gastroenterol Hepatol. Early online, 2014;8(8):851-4.

  43. Zullow, S, Flasar, MH, Greenberg, D, Tracy, JK, Rustgi, A, and Cross, RK. A Health Survey of Gastroenterologist Prescribing Practices of Adalimumab for Treatment of Crohn’s Disease: Final Results. Gastroenterology & Hepatology. 2014;10(8):1-7.

  44. Regueiro, MD, Greer, JB, Binion, DG, Schraut, WH, Goyal, A, Keilo, DJ, Cross, RK, Williams, ED, Herfarth, HH, Siegel, CA, Oikonomou, I, Brand, MH, Hartman, DJ, Tublin, ME, Davis, PL, Baidoo, L, Szigethy, E, and Watson, AR. The Inflammatory Bowel Disease Live Interinstitutional and Interdisciplinary Videoconference Education (IBD LIVE) Series. Inflamm Bowel Dis. 2014;20(10):1687-95.

  45. Ghazi, LJ and Cross, RK. The Role of Telemedicine and E-Health in the Management of Inflammatory Bowel Disease: Improving Patient Outcomes. Smart Homecare Technology and Telehealth. 2015;3:17-24.

  46. Cross, RK, Jambaulikar, Guruprasad, Langenberg, P, Tracy, JK, Collins, JF, Katz, J, Regueiro, M, Schwartz, DA, and Quinn, CC. TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and Implementation of Randomized Clinical Trial. Contemp Clin Trials. 2015;132:132-44.

  47. Joshi, G, Cross, RK, and Flasar, MH. Race and Inflammatory Bowel Disease. Practical Gastroenterology. 2009;33(1):23-33.

  48. Patil, SA and Cross, RK. Update in the Management of Extraintestinal Manifestations of Inflammatory Bowel Disease. Curr Gastroenterol Rep 2013;15(3):314.

  49. Stoddard, PB, Ghazi, LJ, Wong-You-Cheong, J, Cross, RK, and Vandermeer, FQ. Magnetic Resonance Enterography: State of the Art. Inflamm Bowel Dis 2015;21(1):229-39.

  50. Ghazi, LJ, Patil, SA, and Cross, RK. Sexual Dysfunction in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2015; 21(4):939-47.


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